Acuson SC2000 Diagnostic Ultrasound System

Q: What is the product code of K132654?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.

FDA 510(k) K132654 · Siemens Medical Solutions USA, Inc. Ultrasound Gro

Substantially Equivalent

510(k) numberK132654

Submission

Device name: Acuson SC2000 Diagnostic Ultrasound System
Applicant: Siemens Medical Solutions USA, Inc. Ultrasound Gro
Moutain View, CA, US
Received: August 26, 2013
Decision date: September 26, 2013
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

Official FDA 510(k) record

Device classification

Product code: IYO – System, Imaging, Pulsed Echo, Ultrasonic
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1560
Specialty: Radiology

Other 510(k)s with product code IYO

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K252237	EdgeFlow UW20IYO · Traditional	Edgecare, Inc.	04/17/2026SE
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K253898	QT Scanner 2000 Model AIYO · Special	QT Imaging Holdings, Inc.	03/04/2026SE
K253714	IntraSight PlusIYO · Traditional	Philips Image Guided Therapy Corporation	02/24/2026SE
K253221	Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)IYO · Traditional	Eieling Technology (Shenzhen) Limited	02/06/2026SE
K250331	Astrasono A3Pro Bladder Scanner (A3Pro)IYO · Traditional	Astrasono Technology Co., Ltd.	09/30/2025SE
K250381	Deepsight NeedleVue LC1 Ultrasound SystemIYO · Traditional	DeepSight Technology, Inc.	08/01/2025SE
K243227	B-ScanIYO · Traditional	Accutome, Inc. Doing Business AS Keeler USA	07/11/2025SE

More from Accutome, Inc. Doing Business AS Keeler USA

510(k)	Device	Decision
K132804	Acuson S1000 / S2000 / S3000IYN · Traditional	10/24/2013SE
K121646	Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemIYN · Special	06/22/2012SE

Questions and answers

When was Acuson SC2000 Diagnostic Ultrasound System cleared by the FDA?

Acuson SC2000 Diagnostic Ultrasound System (K132654) received a 510(k) decision of Substantially Equivalent on September 26, 2013, 31 days after the submission was received.

What is the product code of K132654?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.